Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC

N/AActive Not RecruitingNCT06808113

IRCCS Azienda Ospedaliero-Universitaria di Bologna40 enrolled

Overview

The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.

The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied. Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with NSCLC in advanced stage (IIIB, IV) * Patients eligible for the treatment with single-agent immunotherapy (Pembrolizumab), or a chemo-immunotherapy combination among the approved ones for I line * Obtainment of the informations related to medical history and the possibility to have an adequate follow up * Obtainment of the informed consent * Age ≥ 18 years Exclusion Criteria: * Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Outcomes

Primary Outcomes

Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC

To determine the plasma levels of GDF15, FGF21, some microRNAs involved in inflammatory processes called inflammamiR and to perform the measurement of telomere length in leukocytes in plasma samples of patients with NSCLC before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. The association between variables of clinical interest and plasma levels of the aforementioned molecules will be evaluated. In particular, the association between their plasma levels and body composition expressed as a percentage of fat mass and lean mass and overall-survival (OS) and progression-free survival (PFS) will be evaluated.

Time frame: The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared

Secondary Outcomes

Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC.

The leukocyte subpopulations of interest (cell. T naïve, cell. T of the central memory, cell. T of effector memory, cell. Suppressive Myeloids, cell. NK) will be reported as percentages per sample. The association between variables of clinical interest and the percentage of different leukocyte subpopulations will be evaluated. The association between percentages of white blood cell subpopulations and OS, PFS will be evaluated.

Time frame: The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared.

Data from ClinicalTrials.gov

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